Summary of medicine characteristics - OTOPLEX ORAL DROPS
1 NAME OF THE MEDICINAL PRODUCT
Otoplex Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml (27 drops) contains:
Aconitum napellus 12X
Capsicum annuum 4X
Chamomilla recutita 0
Echinacea purpurea 0
Hydrargyrum bicyanatum 6X
Hydrastis canadensis 4X
Iodum 4X
Natrium tetraboracicum 4X
Sambucus nigra 0
Sanguinaria canadensis 0
Each ml (27 drops) contains 486 mg of ethanol (see section 4.4. Special warnings and precautions for use’)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops; solution;
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A homeopathic medicinal product used within the homeopathic tradition for the relief of minor earache.
4.2 Posology and method of administration For oral use only.
Take 12 – 15 drops, approximately every 90 minutes, up to 12 times a day, in a glass of water.
Maximum daily dose = 12 × 15 drops (180 drops)
This product is not recommended for use in children under 12 years of age (see section 4.4 ‘Special warnings and precautions for use’).
If symptoms worsen during the use of the product, or persist after 2 days of using the product, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to any of the active ingredients, Echinacea or to other plants of the Asteraceae/Compositae family, or sources of capsaicinoids (e.g. pepper plants or chilli) or to ethanol.
Because of its immunostimulating activity, Echinacea must not be used in cases of
progressive systemic disorders (tuberculosis, sarcoidosis)
autoimmune diseases (e.g. collagenoses, multiple sclerosis)
immunodeficiencies (e.g. HIV infection, AIDS)
immunosuppression (e.g. oncological cytostatic therapy, history of organ or bone marrow transplant)
diseases of the white blood cell system (e.g. agranulocytosis, leukaemias)
allergic diathesis (e.g. urticaria, atopic dermatitis, asthma)
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
Atopic patients should consult their doctor or qualified healthcare practitioner before using products containing Echinacea. There is a possible risk of anaphylactic reactions in atopic patients.
Avoid the product coming into contact with mucous membranes.
If there is discharge from the ear or something is stuck in the ear, do not take this product and consult a doctor.
If symptoms worsen during the use of the product, or persist for more than 2 days of using the product, or fever, worsening or severe ear pain, headache or neck ache, or discharge from the ear occurs, a doctor or qualified healthcare practitioner should be consulted.
Not to be used repeatedly in case of recurrent symptoms without consulting a doctor or qualified healthcare practitioner.
This product is not recommended for use in children younger than 12 years of age and medical advice should be sought.
This medicine contains 53 vol.-% alcohol, i.e. up to 270 mg per dose (15 drops), which is equivalent to 7 ml beer or 3 ml wine per dose.
The small amount of alcohol in this medicine is not expected to have any noticeable effects if taken as recommended.
The concomitant use of other medicinal products that contain ethanol should be avoided.
Drinking alcohol whilst taking this product should be avoided, because the effects of alcohol may be increased.
4.5 Interaction with other medicinal products and other forms of interaction Otoplex Oral Drops should not be taken with other medicines known to interact with alcohol e.g. metronidazole, disulfiram.
Not to be used concomitantly with any immunosuppressant medications such as ciclosporin, methotrexate, azathioprine, sirolimus, tacrolimus, canakinumab, basiliximab, belimumab, mycophenolate mofetil, belatacept.
4.6 Fertility, pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, this product should not be used during pregnancy or lactation.
Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date no other relevant epidemiological data are available. The potential risk to humans is unknown.
Studies on the effects on fertility have not been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on driving or operating machines have been performed.
This product contains alcohol (see section 2).
4.8 Undesirable effects
Echinacea can trigger allergic reactions in atopic patients.
Hypersensitive reactions in the form of rash, urticaria, itching, swelling of the face may occur with Echinacea. Cases of severe hypersensitivity reactions, such as Stevens-Johnson Syndrome, angioedema of the skin, Quincke oedema, bronchospasm with airway obstruction, asthma and anaphylactic shock have been reported. The frequency is not known.
Chamomile preparations can also cause hypersensitivity reactions including severe allergic reaction following mucous membrane contact. The frequency is not known. Association with autoimmune diseases cannot be excluded for Echinacea:
– disseminated encephalitis
– erythema nodosum
– immunothrombocytopenia
– Evans Syndrome
– Sjögren Syndrome
Leucopenia may occur in long-term use (more than 8 weeks).
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
The amount of alcohol in a full bottle of the largest pack size (20.8 g in 50 ml) is equivalent to 219.3 mls of wine or 526.4 mls of beer.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not applicable.
ATC code: V03A All other therapeutic products
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
5.3 Preclinical safety dataTests on genotoxicity, reproduction toxicity and carcinogenicity have not been performed.
Animal studies have shown reproductive toxicity after high subcutaneous doses of capsaicin. Capsaicin crosses the placenta and may pass into breast milk.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Ethanol
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Unopened: 5 years.
Shelf life after first opening: 6 months
6.4 Special precautions for storage
No special storage conditions are required. Store in the original container.
6.5 Nature and contents of container
Amber glass bottle of hydrolytic class 3 with tamper evident cap (white), 2-part, cap of PP, ring of HDPE; dropper insert of LDPE.
Pack sizes: 30 ml and 50 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNo special requirements
7 MARKETING AUTHORISATION HOLDER
Weber & Weber GmbH & Co. KG
Herrschinger Str. 33
82266 Inning/Ammersee
Germany
Phone +49 (0)8143 9270
Telefax +49 (0)8143 927 270
information@weber-weber.net
8 MARKETING AUTHORISATION NUMBER(S)
NR 16672/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
29/03/2022